Good Laboratory Practice Regulations (Drugs and the Pharmaceutical Sciences, 168, Band 168) - Hardcover

Buch 20 von 80: Drugs and the Pharmaceutical Sciences
 
9780849375835: Good Laboratory Practice Regulations (Drugs and the Pharmaceutical Sciences, 168, Band 168)
Hardcover
ISBN 10: 0849375835 ISBN 13: 9780849375835
Verlag: Taylor & Francis Inc, 2007

Inhaltsangabe

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures…gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents…and details the FDA’s GLP inspection program.

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Über die Autorin bzw. den Autor

Sandy Weinberg

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Verlag
Taylor & Francis Inc
Erscheinungsdatum
2007
Sprache
Englisch
ISBN 10 
0849375835
ISBN 13 
9780849375835
Einband
Gebundene Ausgabe
Auflage
4
Anzahl der Seiten
285
Herausgeber
Weinberg Sandy
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Buchbär
info@buchbaer.de

Weberstr. 67
Osnabrück
49084
Deutschland

Weitere beliebte Ausgaben desselben Titels

9780824708917: Good Laboratory Practice Regulations, Third Edition, Revised and Expanded (Drugs and the Pharmaceutical Sciences)

Vorgestellte Ausgabe

ISBN 10:  0824708911 ISBN 13:  9780824708917
Verlag: Marcel Dekker Inc, 2002
Hardcover